Pharmacy benefit considerations for continuous glucose monitoring acquisition: Vermont Medicaid experience

Many individuals with diabetes are not achieving their glycemic goals. Use of continuous glucose monitoring (CGM) improves diabetes management. Access to CGM is often hindered when individuals must acquire their supplies through the traditional durable medical device channel. Vermont Medicaid transitioned CGM coverage from a medical/durable medical equipment benefit to a pharmacy benefit. This improved access and lessened the burden on prescribing health care providers. We describe the process the Vermont Medicaid program implemented to make this transition.


Plain language summary
Use of continuous glucose monitoring (CGM) by individuals with diabetes improves glycemic control. However, acquiring CGM through the traditional durable medical equipment (DME) channel limits access to this technology. It places significant burdens on prescribing health care providers by requiring extensive documentation that supports the medical necessity for each individual. Vermont Medicaid transitioned from the DME channel to the pharmacy channel to expand member access to CGM, lower costs, and reduce health care provider burden.

Implications for managed care pharmacy
Suboptimal glycemic control is predominant within the total diabetes population. However, Medicaid members have higher rates of poor diabetes management, have worse glycemic control, experience more barriers to care, and have more complications compared with individuals covered by commercial insurance. Vermont Medicaid's decision to transition CGM coverage from The Vermont Medicaid program operates under a 100% fee-for-service model and covers approximately 180,000 members in Vermont, representing more than 25% of the state's population. In Vermont, diabetes is a serious health condition that affects more than 40,000 adults and is one of the leading causes of death resulting from a chronic disease. In addition, based on a study that analyzed a national database of 73 million Americans with private health insurance, Vermont had the highest prevalence rate of type 1 diabetes (T1D) among those aged 19 years or younger. 1 Diabetes is also recognized as one of the leading causes of death and disability worldwide. 2 As demonstrated in early studies, persistent elevated glucose levels, as assessed by glycated hemoglobin A1c (A1c), result in a myriad of microvascular and macrovascular complications, including retinopathy, neuropathy, renal failure, and cardiovascular disease. 3-6 Fortunately, we now have medications and technologies that enable individuals with diabetes to achieve desired glycemic control and prevent or delay the progression of these complications.
During the past 5 years, an increasing number of individuals with diabetes have integrated continuous glucose monitoring (CGM) into their Pharmacy benefit considerations for continuous glucose monitoring acquisition: Vermont Medicaid experience daily diabetes self-management. 7 Unlike traditional blood glucose monitoring, which only provides a single, point-intime glucose value, CGM devices automatically transmit a continuous stream of glucose data to users about their current glucose level as well as the direction and velocity of fluctuations. With this information, users can make more informed decisions when calculating insulin dosages, determining dietary intake and modifying their health behaviors. Importantly, this feedback enables users to respond promptly to mitigate or prevent acute hypoglycemia and hyperglycemia.
Large clinical trials have demonstrated that use of CGM in individuals with diabetes is associated with lower A1c levels, greater time in glucose target range, and a reduction in the incidence of severe hypoglycemia and diabetic ketoacidosis in adults and children treated with intensive insulin therapy. [8][9][10][11][12] Recent real-world studies have also shown significant associations between CGM use and reductions in inpatient/outpatient hospitalizations, emergency department utilization, and workplace absenteeism. 13-16 Use of CGM is now the standard of care for individuals with diabetes who are treated with intensive insulin therapy. 17,18 Although CGM offers the potential for improved clinical outcomes, gaining access to this technology can be challenging when obtained as a medical benefit through the traditional, durable medical equipment (DME) distribution channel. Under Vermont Health Care Administrative Rules, Vermont Medicaid covers DME under set conditions, including when it is medically necessary. Providers are required to keep documentation of medical necessity when these items are provided. In an effort to expand patient access to CGM, a growing number of public and private insurers are changing their approach to reimbursement, transitioning CGM coverage from a medical benefit to a pharmacy benefit to reduce costs and improve member access by allowing them to be filled at their local pharmacies.
In this article, we review the key benefits of making CGM coverage available through the pharmacy channel and describe the process the Vermont Medicaid program used to implement this transition.

Rationale for Transition to Pharmacy Channel EXPANDED ACCESS, ENHANCED MEMBER EXPERIENCE
Offering CGM through the pharmacy channel significantly expands member access by making products available at local pharmacies. According to the latest estimates by the National Association of Chain Drug Stores, approximately 9 out of 10 Americans live within 5 miles of a community pharmacy and less than 2 miles in metropolitan areas. 19 Importantly, Vermont Medicaid offers a transportation benefit to Medicaid members, including travel to and from pharmacies. Pharmacy coverage also ensures that members can obtain their CGM products quickly. When obtaining their products from DME suppliers, patients often wait significantly longer for delivery; whereas members can usually obtain their CGM supplies in 1-2 days from their local pharmacy.

COVERAGE CRITERIA
The coverage criteria for Vermont Medicaid specifies that the member requires multiple daily injections of a rapid-/ short-acting insulin or is on an insulin pump. Reauthorization requires documented evidence of compliance to CGM, such as via log data or office visit notes confirming compliance.

REDUCED CLINICIAN BURDEN
Under the traditional DME distribution model, member access to CGM follows a rather onerous documentation process that treating physicians must create and submit to the DME supplier to obtain a prior authorization for coverage. They must ensure that the documentation strongly describes the medical necessity for CGM and provide supporting evidence (eg, blood glucose records, patient history of acute complications, etc). With the transition to pharmacy coverage, physicians complete a simplified, 1-page form documenting medical need for CGM ( Figure 1).
The administrative demand of the process impacts physician practice efficiencies. In a 2009 survey by Health Affairs, physicians reported spending 3 hours weekly interacting with health plans and that nursing and office staff spent much larger amounts of time. Calculated on a national level, the time spent obtaining prior authorizations equates to approximately $23 billion to $31 billion annually. 20 Thus, we found that providing coverage as a pharmacy benefit both minimized physician burden in terms of reduced time and reduced costs.

IMPROVED PATIENT CARE
Although reduced health care provider burden is an important consideration, the primary benefit of pharmacy coverage of CGM is improved quality of care for members. As reported by Pihoker et al, younger members who are covered by Medicaid are more likely to be treated with less intensive insulin therapy and receive fewer changes to their current insulin regimens than those with private insurance, a disparity that is particularly striking among Black and Hispanic patients. 21 It has also been reported that significantly fewer young minority patients are using diabetes technologies in their treatment regimens. 22 Other studies have shown that By covering CGM as a pharmacy benefit, not only is access significantly improved, but also pharmacists are immediately integrated into each member's health care team. Although we did not specifically assess how often pharmacists interacted with members about their CGM, it does provide ample opportunities for pharmacists to offer patient education on the use of CGMs, such as how to use the devices, interpret the reports produced, and adjust insulin dosing, for example. Pharmacists also play a role in regularly assessing members' health status, reviewing their current therapy, identifying therapy-related problems, communicating with other health care providers, and referring members to broader health management programs (eg., weight loss, diet/nutrition counseling, smoking cessation). Through regular, face-to-face interactions with members, pharmacists are positioned to support patient adherence, leading to improved clinical outcomes and lower health care costs. 29

IMPROVED EFFICIENCY FOR VERMONT MEDICAID
For Vermont Medicaid, coverage in the medical benefit was provided through the use of the appropriate medical billing codes but does not require that a National Drug Code (NDC) number be provided on each claim. Therefore, the reimbursement was often not aligned with the product dispensed, and it also was difficult to track accurate utilization of specific products. The transition to pharmacy coverage provided the ability to track CGM supplies by the NDC number and monitor trends in utilization and, thereby, improved our ability to manage costs. In addition, staff burden was reduced because these claims were previously being manually priced in the DME benefit. Now, all pricing is done automatically through the pharmacy channel. Overall, the transition not only resulted in significantly lower administrative costs but also provided more accurate reimbursement resulting in cost savings to the Medicaid program. Lastly, the change also expanded access to CGM among Medicaid members.

TRANSITION PROCESS
Vermont Medicaid followed a step-wise approach when initiating the changeover from DME to the pharmacy channel. The goal was to ease into the transition to avoid any disruptions in members' access to their CGM supplies (eg, sensors, transmitters) during the transition period. 1. Estimate economic impact. As a starting point, we estimated the number of members with active prior authorizations in the DME channel who would transition to the pharmacy channel. This allowed us to assess the scope of the transition and determine the potential budget impact.
Overall utilization increased, but the transition resulted in significant savings per device because of lower net costs in the pharmacy benefit. Prior to implementation, overall utilization of CGMs averaged approximately 234 members per year. One year after implementation in the pharmacy benefit, utilization had increased to 470 members per year, representing more than a 100% increase.
We believe that part of this increase in utilization is attributable to improving access through pharmacies, as well as relaxing the coverage criteria because of the COVID-19 public health emergency for a period of time in 2020. In addition, the American Diabetes Association treatment guidelines expanded its recommendations for CGM use to include individuals with type 2 diabetes who are treated with intensive insulin regimens. 30 2. Notify DME providers. DME providers were notified about the transition and instructed to no longer fill prescriptions for CGM devices after October 01, 2021. We also did personal outreach to high-volume DME providers to address their issues and concerns. 3. Notify pharmacies. Pharmacies were notified early about the transition to allow time to raise inventory levels and prepare for billing. All existing prior authorizations were carried over from the medical benefit to the pharmacy benefit to avoid provider burden and member disruption.
A list of members with current and active prior authorizations on file in the Medicaid Management Information System was provided to Change Healthcare, the pharmacy benefits administrator for the Department of Vermont Health Access to facilitate a smooth transition. This allowed Change Healthcare to contact prescribing providers to obtain necessary information to ensure continued access.

Notify CGM prescribers. Prescribers of CGM devices
were notified about the closure of the medical/DME benefit and movement to pharmacy channel. 5. Notify the public. Public notice was issued 30 days prior to implementation. However, the Department of Vermont Health Access did not individually notify Medicaid CGM users.

Easing the Transition
Throughout the transition period, we kept stakeholders informed about the rationale for and benefits of the changes. The first step was to inform prescribing clinicians and pharmacies that CGM will now be covered only as a pharmacy benefit and that prior authorizations had been simplified. We explained that this transition will make it easier and faster for Medicaid members to obtain their supplies. We also explained that prescribers will be able to send prescriptions electronically to the pharmacy or provide paper prescriptions to patients and claims will be adjudicated in real time in the pharmacy claims processing system.

Conclusions
A significant percentage of individuals with diabetes are not achieving their glycemic targets. 31,32 Although suboptimal glycemic control is predominant within the total diabetes population, Medicaid members have higher rates of poor diabetes management,

Pharmacist #1
• "We've had a fair amount of utilization from members over the last several years. I think the biggest beneficial impact has been with pediatric endocrinology and their newly diagnosed T1D patients. Unfortunately, most of those patients come in acutely ill and require a multiday hospital stay. Now with the ability to get the CGMs in retail we are able to get the PA put into place by working with the in-house case managers and provide the CGM usually for the patient to go home with at the time of discharge and schedule an outpatient CDE to review its use the same day before the patient has even walked out the door." • "It also cuts out the waiting period in situations where patient may have not realized they were on their last transmitter or sensor and need to replace it the same day. We keep a consistent stock of all CGMs on hand so in a pinch, we will always have what a patient needs last minute which is greatly appreciated by the utilizers. Even the best DME suppliers can't get it to a patient same day and the local DME providers don't keep them in stock."

Pharmacist #2
• "Yes, it has been helpful that you have opened up access. I can think of several people that probably would not have started using the CGM if it wasn't so easy. I don't think the general public realizes that you have opened up access. The more pharmacies and physicians educate patients about the process, the more customers will take advantage of them. I feel that CGM are not good for everyone, but I think there are a lot more people out there that they would be great for, and better control their diabetes." CDE = certified diabetes educator; CGM = continuous glucose monitoring; DME = durable medical equipment; PA = prior authorization; T1D = type 1 diabetes.
Pharmacist Feedback (With Permission)  TABLE 1 have worse glycemic control, experience more barriers to care, and have more complications compared with individuals covered by commercial insurance. 33 Moreover, among Medicaid members, health care costs for people with diabetes are 1.5 to 4.4 times more than for those without diabetes. 34 Although Vermont has comparatively small minority populations, racial and socioeconomic disparities in diabetes care, particularly in the utilization of medical technologies continues to be a significant health issue for many Medicaid beneficiaries across the country. Given the demonstrated benefits of CGM in improving glycemic control, reducing hospitalizations, and lowering health care costs, it is critical that members who are treated with intensive insulin therapy have unfettered access to this technology. Transitioning CGM coverage from traditional DME suppliers to the pharmacy channel expanded member access to CGM, reduced health care provider burden, increased Vermont Medicaid staff efficiency, and reduced costs to the health plan.